Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-28 @ 1:42 AM
Study NCT ID:
NCT06819904
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2024-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for mTBI: A Targeted Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) with usual care vestibular rehabilitation (VESTIB CONTROL) in 250 individuals with mTBI-related vestibular symptoms attributable to mild traumatic brain injury (mTBI) treated at one of two sites (1) the University of Pittsburgh Medical Center, or (2) the Intrepid Spirit Center, Carl R. Darnall Army Medical Center, Fort Hood, Texas. Both interventions will be delivered weekly over 4 weeks. Assessments will be administered prior to the start of treatment (Baseline) and at 4-weeks, 3- and 6-months following the completion of treatment.
Detailed Description:
Nearly 378,000 mTBIs have occurred among U.S. military service members (SM) since 2000. These injuries result in myriad symptoms (e.g., dizziness, headache, fogginess) and impairments (e.g., cognitive, ocular, vestibular) that typically resolve within a month. However, many SMs experience symptoms and impairment lasting months or longer, resulting in limited operational readiness and duty restrictions. As such, one of the challenges related to mTBI and psychological health issues in military SMs is identifying and implementing timely and effective treatments that address these symptoms in an integrated manner and mitigate downstream problems.
Interventions are needed to target comorbid mTBI and psychological health symptoms. Previous research suggests that targeted vestibular rehabilitation combined with behavioral management (physical activity, sleep, nutrition, hydration) is effective in improving vestibular symptoms and associated functional impairment and reducing recovery time following mTBI. Acceptance and Commitment Therapy (ACT) is a trans-diagnostic cognitive-behavioral therapy based on incorporation of mindfulness and acceptance-based work into traditional behavior therapy. ACT is designed to improve psychological health, functioning, and well-being by improving psychological flexibility or the ability to remain present in the moment despite emotional distress.
There is separate evidence for the effectiveness of targeted vestibular rehabilitation combined with behavioral management interventions, and ACT in regard to enhancing recovery from mTBI and PH, respectively. However, researchers have yet to synergize these approaches to evaluate their effectiveness in military SMs following mTBI involving vestibular and psychological health domains. Our overarching hypothesis is that a combined, brief (\<4 weeks) intervention involving both ACT and integrated vestibular rehabilitation (ACTIVE) will reduce symptoms, impairment, and functional limitations, and accelerate return to activity among military SMs and civilians following mTBI with vestibular symptoms/impairment compared to usual care vestibular rehabilitation (VESTIB CONTROL). The investigators believe that the potential synergy of these combined interventions could provide a more efficient and effective treatment strategy that could mitigate downstream psychological health morbidity in the estimated 60-65% of SMs with vestibular symptoms and impairment following mTBI.
Interventions are needed to target comorbid mTBI and psychological health symptoms. Previous research suggests that targeted vestibular rehabilitation combined with behavioral management (physical activity, sleep, nutrition, hydration) is effective in improving vestibular symptoms and associated functional impairment and reducing recovery time following mTBI. Acceptance and Commitment Therapy (ACT) is a trans-diagnostic cognitive-behavioral therapy based on incorporation of mindfulness and acceptance-based work into traditional behavior therapy. ACT is designed to improve psychological health, functioning, and well-being by improving psychological flexibility or the ability to remain present in the moment despite emotional distress.
There is separate evidence for the effectiveness of targeted vestibular rehabilitation combined with behavioral management interventions, and ACT in regard to enhancing recovery from mTBI and PH, respectively. However, researchers have yet to synergize these approaches to evaluate their effectiveness in military SMs following mTBI involving vestibular and psychological health domains. Our overarching hypothesis is that a combined, brief (\<4 weeks) intervention involving both ACT and integrated vestibular rehabilitation (ACTIVE) will reduce symptoms, impairment, and functional limitations, and accelerate return to activity among military SMs and civilians following mTBI with vestibular symptoms/impairment compared to usual care vestibular rehabilitation (VESTIB CONTROL). The investigators believe that the potential synergy of these combined interventions could provide a more efficient and effective treatment strategy that could mitigate downstream psychological health morbidity in the estimated 60-65% of SMs with vestibular symptoms and impairment following mTBI.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HT94252320064 | OTHER_GRANT | Department of Defense | View |